Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367556
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-10
Brief Title:
Emotion and Symptom-Focused Engagement EASE for Caregivers
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Emotion and Symptom-Focused Engagement EASE for Caregivers A Phase III Randomized Controlled Trial of an Intervention Targeting Traumatic Stress in Parents of Children With Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EASE
Brief Summary:
The goal of this two-site Phase III randomized controlled trial is to evaluate the effectiveness of a novel psychotherapeutic intervention called Emotion and Symptom-focused Engagement EASE in parents caring for a child or adolescent with cancer The main question it aims to answer is
- Does EASE reduce traumatic stress symptom severity primary outcome
To do so researchers will compare parents receiving EASE to usual care Participants in both groups will complete questionnaires package at enrolment and 4 8 and 12 weeks and 6 months after enrolment They will also be invited to participate in optional qualitative interviews to better understand their experience
- Does EASE reduce traumatic stress symptom severity primary outcome
To do so researchers will compare parents receiving EASE to usual care Participants in both groups will complete questionnaires package at enrolment and 4 8 and 12 weeks and 6 months after enrolment They will also be invited to participate in optional qualitative interviews to better understand their experience
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None